ISO 13485:2016 standard

We are pleased to announce, we have recently been certified to the ISO 13485:2016 standard, an internationally recognized quality system standard, signifying the Quality System at Medifactia AB, which ensures processes are in place to address quality system aspects related to medical devices.

This ISO 13485:2016 upgrade shows Medifactia´s commitment to providing agreed levels of quality care and patient safety to the manufacturing of Transit-Pellets radiopaque markers, and the same high levels of conduct in our business practices. With this new achievement, we are also preparing ourselves for the requirements of the new European Medical Device Regulation (MDR) 2017/745.

Updated carton label

In connection with the next Medifactia Transit-Pellets batch, the Transit-Pellets packages will be labeled with an updated carton label.

Change of Corporate Address

Effective September 1st, Medifactia’s corporate address has been changed as follows:

Medifactia AB
Kungsgatan 60
111 22 Stockholm

Other contact information such as phone number(s) and email address(es) remain the same.


In connection with the next Medifactia Transit-Pellets batch, the Transit-Pellets packages will be labeled with an updated carton label. The only difference between the current and updated label is Rx Only and the UDI (GTIN) number.

In addition, we have updated the IFU (package insert). Please note that the content has not been changed but we have added five additional translations.


UDI/article number 0 7350099 55001 0 inserted. The revised EC Certificate is available under DOCUMENTS.

EC Certificate

The EU Medical Device Regulation (MDR), originally scheduled to go into effect May 26, 2020, will now take effect May 26, 2021 due to the impact of Covid-19.

Manufacturer have had the option of re-certifying MDD certifications to buy some time for compliance with the EU MDR. With that said, there has been certification processes required for MDR that are not delayed and need supporting document and product data.

Re-certification under MDD will enable manufacturers to keep their products on the market until May 2024 or the re-certification expiration date, whichever comes sooner. As mentioned above, a re-certification under MDD is dependent on certain circumstances related to the manufactures current MDD standing including the absence of possible gaps in their compliance activities. For example, if not already implemented, a system for risk management, vigilance and post-market surveillance has to be implemented and interlinked as integral parts of the overall quality management.

In the fall of 2019, Medifactia requested a re-certification audit to extend the validity of Medifactia’s Transit-Pellets radiopaque markers EC Certificate. We are happy to announce that Medifactia’s re-certification under the MDD was approved in April 2020.

We have begun the transitioning and plan to make the full MDR transition in 2023.

FDA 510(k) Class II clearance

Transit-Pellets radiopaque markers FDA 510(k) Class II clearance for the US-market!


We are pleased to announce the relocation of our office effective date September 1st, 2018.
Please update your records with our new contact information:

Postal address: Medifactia AB, Lumaparksvägen 7, SE 120 31 Stockholm

Visiting address: Ljusslingan 4, 8th floor, SE 120 31 Stockholm

Our new phone number effective date September 1st, 2018:
+46 (0) 8 – 460 072 06

Our other contact information will remain the same.

Please feel free to contact us with any questions.

IMPORTANT INFORMATION – Correction is advised

We would like to call your attention to the fact that each capsule in a box of Transit-Pellets™ is Vegetable base, with no use or traces of animal products, i.e gelatin capsules, which we use to state in our old Transit-Pellets™ Information Material. This has now been corrected and we would like to advise you to do the same. To view the complete table of contents, please see Patient Information Leaflet.


Upcoming Event – Gastrodagarna

Where: Gothenburg, Sweden
When: 2017.05.17-2017.05.19

Stop by Medifactia’s booth during the three day congress for exposure to our full offerings: Transit-Pellets™ and Transit-Pellets™ Monitoring System.

Learn more about Transit-Pelletsmethod™ (formerly known as ‘Abrahamsson Method’) from the founder himself, Professor Hasse Abrahamsson.

Professor Hasse Abrahamsson
Measurement of transit time in clinical practice. How to measure, when to measure and how you use the results.

This luncheon is a one-stop-shop for you to evaluate the benefits of colonic transit tests for your patient’s and to learn more about Transit-Pelletsmethod™ (formerly known as “Abramsson’s method) from the founder himself, Professor Hasse Abrahamsson.

Professor Magnus Simren
– Professor Magnus Simrén, Sahlgrenska University Hospital, Gothenburg
– Associate Professor Susanna Walter, Linköping University Hospital
– Professor Wilhelm Graf, University Hospital, Uppsala

Optimal management of patients with chronic constipation, 2017.

Update on the latest knowledge in the treatment measures and investigation time for patients with chronic constipation. The speakers will provide a comprehensive picture of the area and highlight the physiology relevant investigation, review of existing drugs and how they can be used as well as various non-pharmacological treatments. Within the non-pharmacological field will substances biofeedback and surgical methods (e.g., sacral nerve stimulation) discussed but also diet and exercise.

Recently published an international Delphi study, F-PAR. There is a consensus report for the acting of patients where current treatment does not provide adequate help. Results and checklist from this publication also touches the symposium.